The final consortium meeting of StimulAIS project has been arranged by TEQUIR (Project Coordinator). This meeting will take place in Valencia, Spain, on Tuesday 10th March 2015.

All consortium partners will be represented in the meeting and will have the opportunity to discuss about the work progress carried out in the last stage, as well as to share the results achieved, according to the expected milestones.

Conference: “Myoelectric imbalance in the coupled activity of the superficial long paraspinal muscles and the deep rotators at both sides of the curve in patients with idiopathic scoliosis. Direct intramuscular recording in different spine tasks”

More than fifty Researchers Attended the X INVESCOT 2014 National Conference of the Spanish Association for Research in Orthopaedic Surgery and Traumatolgía held at the Medical Surgical Hospital in Santiago de Compostela Conxo.

After technological development stages, three main results have been successfully achieved and integrated in a working active implantable medical device, in accordance with EU directives, for performing customized treatment of AIS:

R1. The implantable device is programmable (for sensing and stimulating) in order to provide a wide range of treatment protocols, while muscle selectivity will allow targeted stimulation to maximize treatment outcome. Moreover, the integrated stimulation control software (to modulate it into safety thresholds) implements an innovative technology with sensor (EMG) and motor function, which will allow real-time adaptation in order to maintain stimulation effectiveness and provide progressive correction of the pathology.

All these features are integrated in a small device with low obtrusiveness providing the advantages of fully implanted systems with a minimally invasive associated procedure.

R2. Specific surgical instruments were developed in order to implant the electro-stimulation device and for the connection of electrodes to the key muscles. The minimally invasive surgical technique was validated in-vitro with the developed instruments, and ensures a short hospital stay.

R3. The external console to program the subcutaneous device and to collect bioelectric data of the patient. It consists of a reader for wireless communication with the implanted device and a control software with an intuitive user interface. This will be handled by clinicians for programming the implantable device with the most appropriate stimulation protocol and follow-up treatment.

This way, most initial project aims have already been fulfilled, providing the consortium the valuable experience about the industrial and regulatory contexts of the final product, for its future commercial realization.

Prototypes were manufactured for being used in definitive animal experiments, according to the procedures authorized by the ethics committee. Animal experimentation allowed us to verify the functioning and operation of the integrated StimulAIS system. However, the animal experimentation has been troublingly tough. We could not see all envisaged results from the implanted devices to verify the full functionality of the device in-vivo (e.g. EMG measures for customized treatment), and some detected limitations have required complementary components development for being used with the animals, in order to get access to information or to improve in-situ usability.

Overall, the consortium’s aim for the next follow-on project is to produce a prototype validated industrially according to all the applying regulatory framework, for CE marking. Achieved in collaboration with specialized providers, this version of the product will participate in phase two and three clinical trials, in order to validate the device in humans. To achieve maximum impact, project promoter (Tequir) is leading the search for manufacturing and clinical partners who can upwardly scale production towards industrial volumes, and license StimulAIS technology – a prospect that is also an inviting business opportunity.

Further dissemination and exploitation activities are envisaged for consortium partners after project end, in order to facilitate and encourage the industrial and commercial exploitation of the results, while generating clinical evidence of StimulAIS system.

As part of the Dissemination Plan, Fraunhofer-IPMS has participated with a trade-show booth at MEDICA fair, celebrated in Dusseldorf (12-15 November 2014), for presentation of the StimulAIS active implantable device.

Dr. Eng. Andreas Heinig (from IPMS) has presented the StimulAIS active implantable device, and attended target stakeholders in the medical sector about its application and functionalities.

StimulAIS consortium has participated in the development of dissemination activities (in the frame of the dissemination plan), in order to promote R&D achievements.

Result of this work is the attached article "Non-invasive treatment for spinal curvature in children", where, after providing a context of the AIS pathology, the updated project progress is exposed.

Several of the project’s initial aims have already been fulfilled, bringing StimulAIS’ novel
proposition significantly nearer to commercial realisation. Initial prototypes have been prepared for ethics committee authorisation of definitive animal experiments, which must
precede in vivo tests on humans and full rollout into the marketplace.

An overview of next follow-on project aims is provided in order to validate the full system in clinical trials and up-scale production towards industrialization.

StimulAIS project has been selected for a special edition publication due to its relevance in the healthcare sector, and it will be published together with other cutting edge technological projects in "Science, technology and innovation PROJECTS. Issue 37" (by INSIGHT Publishers).

The article can be downloaded by clicking in the title of this dissemination note.

The 18-months meeting of StimulAIS project had been arranged by Synimed. This meeting took place in IBV facilities, Valencia, Spain, on Wednesday May 21st, 2014.

All consortium partners were represented in the meeting and had the opportunity to share the state of the results achieved so far, as well as discuss about the work progress, next tasks and expected results (functionality, definitive prototypes assembly, animal experimentation and validation of StimulAIS system), giving rise to the most critical issues for a successful consecution of the next milestones in the last stage of the project.